Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
FDA 510(k) clearance K153149 · decided 2016-05-27
Clearance details
- K-number
- K153149
- Device name
- Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
- Applicant
- Sejoy Electronics & Instruments Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-30
- Decision date
- 2016-05-27
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hang Zhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.